
Member of the FDA’s Psychotropic Drugs Advisory Committee The vote was 9 to 2. against supporting the efficacy of MDMA as a treatment for PTSD, 10-1 Negates the question of whether the benefits outweigh the risks.
The FDA designated MDMA-assisted therapy a “breakthrough therapy” in 2017. Lycos Therapeutics To approve proposed treatments for PTSD.
This is the United States Schedule I Drugs Medical Use. A substance listed as Schedule I means that it has no accepted medical use and has a high potential for abuse.
“I am disappointed that the FDA advisory committee ignored the voices and testimony of veterans whose lives have been forever improved by MDMA-assisted therapy, and instead voted in favor of those who seek to discredit this promising treatment at all costs,” Rep. Jack Bergman (R-Mich.), a former Marine Corps Lt. Gen., told The Hill.
“This is the first treatment that’s expected to revolutionize psychiatric care in 50, 60 years, and you’re going to turn that down? Are you kidding me?” Rep. Lou Correa (D-Calif.), co-chair of the Congressional Psychedelic Therapy Caucus with Bergman, told The Hill in an interview.
Panelists said they were excited about the results, but treatment is still ongoing. Too experimental.
“While we are disappointed with the outcome of the vote, we will continue to cooperate with the FDA’s ongoing review,” Lycos CEO Amy Emerson said in a statement. “New effective, accessible treatments are urgently needed to address the unmet needs of people living with PTSD.”
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